DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant Claims 1-21 do not benefit from the filing date of the parent applications 17/468460 and 16/424202, as the parent applications do not adequately support the full scope of the claims. For a claim in a CIP to benefit from the dates of the parent applications:
The later-filed application (CIP in this case) must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 17/468460 and 16/424202, each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, Claim 1 recites “sensing the native electrical biopotential signal using at least one electrode on the Huygens catheter to generate a well-formed waveform of the biopotential showing electrical properties indicative of the tissue with a SFDR of at least 24.9dB and SNR of at least -13dB”. A person having ordinary skill in the art before the effective filing date of the claimed invention would not have reasonably concluded from the disclosure of the prior-filed applications possession of the full scope of “sensing the native electrical biopotential signal using at least one electrode on the Huygens catheter to generate a well-formed waveform of the biopotential showing electrical properties indicative of the tissue with a SFDR of at least 24.9dB and SNR of at least -13dB”. At best, application 17/468460 describes a generic “improved SFDR” (¶47) and mentions an SNR of 10 (unitless) in ¶112: “Signals in the EP lab range from 25 pV (scar related signals) to 5 mV (surface ECG). Noise on clean EGM's is on the order of magnitude of less than 20 pV, when everything is properly grounded and shielded. So achieving a SNR of 10, for example, with a biologic signal of 25 pV and a noise of 2.5 pV, is considered good”, which doesn’t even disclose achieving that “SNR of 10” with any device. Thus, the prior-filed applications do not provide adequate support for Claims 1-20 (dependent claim analysis not required at this stage, as Claim 1 is not supported). See MPEP 2163, 2163.05. Therefore, the effective filing date of Claims 1-20 is 3/3/23.
Specification
The disclosure is objected to because of the following informalities:
1) The use of the term “Huygens” (catheter or sensor array), which is a trade name or a mark used in commerce, has been noted in this application (¶7-8,13,16,19-24, and so on). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
2) Paragraph 2 of the specification should be updated for any issued patent numbers.
Appropriate correction is required.
Drawings
The drawings are objected to because it is not clear what the placeholders “XX”, “XXX”, “XXXXX” (etc.) are meant to replace and convey in Figures 1-3,5, and 8. No new matter should be added to replace these placeholders. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-21 are objected to because of the following informalities: 1) In claim 1, “24.9dB” should be “24.9 dB” and “-13dB” should be “-13 dB”, 2) In claims 2-21, there should be a comma right after the recitation of the parent claim number (e.g. “The method of claim 1 where” should be “The method of claim 1, where”), 3) in claim 6, “the energy contents” should be “energy contents”, 4) in claim 13, line 2, “configurations” should be “configuration” . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
1) Claim 1 contains the trademark/trade name “Huygens sensor array” and “Huygens catheter”, which are trademarks according to the specification (see ¶7,19-20). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a sensor array and a catheter and, accordingly, the identification/description is indefinite.
It is suggested that Applicant explicitly recites the structure that defines the sensor array and catheter that is claimed by a trademark name in leu thereof.
2) Claim 1 is drawn to “[a]n improvement to a method” rather than a method. Improvements to methods are reserved for Jepson claims, as permitted by 37 CFR 1.75(e). The same rule requires “A preamble comprising a general description of all the elements or steps of the claimed combination which are conventional or known”. This part is missing from the claim. Therefore, it is not clear what method is meant to be improved by the claim. This improper and incomplete format of a Jepson claim is thus unclear as to the scope of the claim. See MPEP 2129.III.
3) Regarding Claim 1, the terms “proximate to” is subjective and relevant, making the metes and bounds of the claimed invention. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be apprised with reasonable certainty of the scope of the invention.
4) Regarding Claim 1, “the Huygens catheter” in line 4 lacks clear antecedence.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Schachar “The Use of Local Amplifier and MOSFET Sensor Array in Measuring Bioelectric Signals and Its Clinical Applications”, 1/2018 (submitted by Applicant with the IDS of 12/19/24) in view of US 20150313501 by Shachar (“Shachar ‘501” herein).
Claim interpretation notes:
The positively recited active steps in Claim 1 are “providing a Huygens sensor array …and sensing the native electrical biopotential using at least one electrode on the Huygens catheter”.
As noted in the 112 rejection section, the “improvement in a method of sensing biopotentials in tissue” are incomplete and unclear as they are directing the claims to be Jepson claims, yet they do not inform of the particulars of the prior art method being improved. Nevertheless, it must be a method of sensing biopotentials in tissue, thus the claims do require, albeit admit that was known to do so, “sensing biopotentials in tissue”.
While these notes focus on Claim 1, it is generally noted that most of the claims are heavily focused on intended results (or other characterizations that do not add steps to the method), rather than steps to achieve the intended results. It is suggested that the claims are amended to focus on and include all the method steps necessary to achieve any claimed intended results. Positively recited steps should be presented in a separate line, beginning with the action taken in the present participle. An undisputable method claim has clauses that are designated by a present participle and separated with a comma (or a semicolon that includes a comma). See Credle v. Bond, 25 F.3d 1566, 1572 (Fed. Cir. 1994).
Regarding Claim 1, Shachar teaches an improvement in a method of sensing biopotentials in tissue comprising:
providing a Huygens sensor array characterized by native biopotential signal sensing with local amplification and signal processing proximate to electrode signal pickup (e.g. abstract, page viii, last paragraph, page ix, par. 1: catheter with local amplifier MOSFET sensor array at the distal end of the catheter shaft configured to amplify the native signal; also see section “The Proposed Solution: MOSFET Sensor Technology”, first three paragraphs and section “Signal Fidelity of Pre-Amplified (MOSFET)”: local amplification which acts as a variable resistor with local ground, and without post-processing of the native signal, ie. all processing is local; Also note that MOSFETs are transistors, thus are fundamental processors of electrical activity to binary output); and
sensing the native electrical biopotential signal using an electrode on the Huygens catheter (e.g. abstract: decapolar catheter with MOSFET sensor array) to generate a well-formed waveform of the biopotential showing electrical properties indicative of the tissue with a SFDR of at least 24.9dB and SNR of at least -13dB (e.g. abstract: MOSFET sensor array signal is well-formed with clear cardiac properties, an SFDR of 24.9dB and an SNR of -13dB).
The method being “an improvement in a method of sensing biopotentials is tissue”, the claimed sensing must be in tissue, something which Shachar does not explicitly teach, as the experiments are conducted with a simulated signal.
However, Shachar ‘501 teaches an analogous EP catheter with a local amplifying MOSFET at the distal end of the catheter (e.g. abstract, ¶7,9,11,34,36,39: cardiac tissue EP catheter with local amplifier MOSFET analog front end to measure biopotentials in tissue) which achieves an SNR of -13dB in sensing biopotential in tissue (¶37: the cardiac EP catheter achieves an SNR of -13db, exactly like Shachar’s simulated results). Furthermore, the claims (Jepson claim preamble) admit that it was known to sense biopotentials in tissue. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Shachar, for local MOSFET biopotential native signal sensing, in actual tissue (in vivo, ex vivo, in situ etc.), as taught by Shachar ‘501, as this would only amount to applying a known technique to a known device and method ready for improvement to yield the predictable result of sensing native biopotentials in tissue with enhanced fidelity.
Regarding Claim 2, Schachar teaches the method of claim 1 where the tissue comprises cardiac tissue and where the biopotential signal comprises a native cardiac waveform (e.g. Shachar ’501, ¶36: cardiac EP detection).
Regarding Claim 3, Schachar teaches the method of claim 1 where the biopotential signal comprises a manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue (e.g. Shachar, page viii: “Electrograms are a manifestation of the underlying electrochemical activity of a biological substrate”; page xi: “the native bioelectrical signal in the form of ionic electrochemical avalanche dynamics can be addressed by locating the preamplifier (MOSFET) element adjacent to the measurement site”).
Regarding Claim 4, Schachar teaches the method of claim 3 where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises an energetic event characterized by vectorial direction and magnitude (e.g. Shachar, page xvi: “This is an important observation that a complex arrhythmia cannot be assumed to be defined as well as treated unless the underlying mechanism and precise identification of the vectorial direction as well as its magnitude can be established”; page xxii: “The aim of the novel technology using transistorized electrodes (i.e., the MOSFET local amplifier circuit) is to accurately identify the conduction path. An ideal conductor might, in general, satisfy the accuracy representation employed by the current art, but in a disease modeling, most of our assumptions relating to linear behavior of the conduction path (the cable theory) cannot be reproduced by such modeling, due to the impact of secondary and significant noise generating phenomena such as vectorial multiplicity of sources generating the EGM, magneto-electric anisotropy, conduction in cardiac strand where gap-junction-mediated mechanisms alternate, and where the standard 'cable theory' does not satisfy the ionic conservation law, and where Navier-Stokes equations with its Diffusion modeling, might be a better approximation of the ionic conduction – its energetic vector with its magnitude and direction then the description provided by the cable theory.”; page xxvii: “A second argument cited directly by analytical and clinical observations is a study by
Shachar and Farkas 23, demonstrating analytically the relationship between conduction
path and the vectorial representation of anisotropic influence of the magnetic dipole
vector on the conduction path. The preceding argument will clarify the behavior of the
Poynting energy vector (PEV) further indicating the fact that representation of the
ECG signal with its post-processing modality is a very crude approximation of the native
bioelectric signal.”)
Regarding Claim 5, Schachar teaches the method of claim 3 where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises a representation of underlying substrate composition of the tissue (page viii: “Electrograms are a manifestation of the underlying electrochemical activity of a biological substrate, and the attempt to functionalize and fashion a diagnostic value upon such graphical representation must first assume that the fidelity of the measured native signal is a true representation of an "energetic event," as energy with its vectorial direction and magnitude is the appropriate setting for a diagnostic measure. Paraphrasing Feynman's sentiment, we ask, "Can the electrogram path represent the underlying substrate composition?"; page xx: “The electrical properties of the conduction path within the substrate and its etiological constituents (e.g., cellular matrix composition and its electrical counterparts) are correlated without the need to create a causal dependency after the fact. This allows for the formation of a robust and coherent standard model in forming the diagnostic basis for defining a disease model, as noted by Tusscher et al. 's study presented at Europace.”)
Regarding Claim 6, Schachar teaches the method of claim 3 where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises a biopotential measurement using the Huygens sensor array to generate a representation of the energy contents on the spatial and time domains of a complex cardiac waveform, leading to a recursive relationship between a graphical representation of the cardiac waveform and an underlying biopotential substrate which is a source of the cardiac waveform (page ix: “ Our approach to the existing measuring apparatus (employing electrode(s) with amplifier at the distal end of the catheter shaft), is compared with use of the novel technology we term in general as local amplifier-MOSFET sensor array, with capabilities enabling an accurate "one-to-one" correlation while forming an electrophysiological map. The biopotential measurement using such technology substantially improve the representation of the energy contents on the spatial and time domains of the complex waveform, leading to a recursive relationship between the graphical representation and the underlying biopotential substrate which causes such electrical activity.”).
Regarding Claim 7, Schachar teaches the method of claim 3 where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises a mapping technique which characterizes global dynamics of cardiac wavefront activation based on cellular etiology and corresponding dielectric (x) and conductivity (σ) characteristics of the tissue representing complex inter-relationships of avalanche dynamics translated through a measured myocardial space arising from spatial and temporal ionic potentials measured by a local amplifier Huygens sensor array (page ix-x: “One of the foremost goals of the EP community is to develop a comprehensive mapping technique so as to characterize the global dynamics of wavefront activation. This must, first, be anchored in a bottom-up consensus where the elementary building blocks are accepted and agreed upon metrically, and whereby the cellular etiology and its electrical counterparts - e.g., dielectric (K) and conductivity (a) - are defined. The complexity and inter-relationships of the "avalanche" dynamics which are translated through the myocardial space, due to ionic potential on the spatial as well as time domains, can be resolved by the use of heuristic top-down causal theory, when employing the local amplifier-MOSFET sensor array.”).
Regarding Claim 8, Schachar teaches the method of claim 1 where sensing a native electrical biopotential signal using at least one electrode on a catheter with an amplifier circuit placed on the inner surface of the at least one electrode in the Huygens sensor array comprises sensing by performing impedance spectroscopy (section “The Proposed Solution: MOSFET Sensor Technology”, first paragraph: impedance spectroscopy at the event site of the biopotential signal; Also see abstract: amplifier in inner surface of the electrode).
Regarding Claim 9, Schachar teaches the method of claim 1 where sensing a native electrical biopotential signal using at least one electrode on a catheter with an amplifier circuit placed on the inner surface of the at least one electrode in the Huygens sensor array comprises sensing an energetic event represented by the native electrical biopotential signal in the tissue by relating its inherent characteristics of time, magnitude and direction without post-processing of the native electrical biopotential signal (page x: “The MOSFET technology that we advocate herein utilizes impedance spectroscopy at
the event site of the biopotential signal. Just as microscopy provided for magnification
which produced a novel view of matter at orders of magnitude which were then
imperceptible, impedance spectroscopy provides an additional tool in the armamentum
of the electrophysiologist that can resolve the distortions caused by the noise of the
current art and further in order to study the inherent relationship between the substrate
and its electrical activity counterpart”; Also see abstract: amplifier in inner surface of the electrode).
Regarding Claim 10, Schachar teaches the method of claim 1 where sensing a native electrical biopotential signal using at least one electrode on a catheter with an amplifier circuit placed on the inner surface of the at least one electrode in the Huygens sensor array comprises sensing the native electrical potential signal using a local amplifier which acts as variable resistor with an on-site electrical ground, which ground is not subject to noise pickup to improve signal-to-noise ratio (SNR), spurious-free dynamic range (SFDR), signal fidelity, sampling rate, bandwidth, and differentiation of far-field from near- field components of the sensed native electrical potential signal (page xi: “The shortcoming of the current electrode technology is emphasized by compression with the substantial improvements provided by the novel technology presented herein, which we title in a generic form as "MOSFET." Simply stated, a local amplifier which acts as variable resistor, and its on-site electrical ground (i.e., a ground not subject to the 5-ft. antenna/conductor, formed out of the catheter shaft, acting as a receiver/carrier for equipment located at the operating room with frequencies ranging from 50-60 Hz to 5-10 kHz, and where such an antenna is the origin for some of these noise generating sources). The novel approach employs pre-amplification technology which substantially improves Signal-to-Noise Ratio (SNR), Spurious-Free Dynamic Range (SFDR), signal fidelity, sampling rate, bandwidth, differentiation of far-field from nearfield components, further outlined in this introduction and the accompanying patents provided.”).
Regarding Claim 11, Schachar teaches the method of claim 1 further comprising using the Huygens sensor array with a conventional mapping station without alteration of the mapping station (page xvii: “The MOSFET sensor array, as a model for local preamplification in supplement to the current electrode technology, provides benefits by
complementing the existing technology when incorporated therein. The current
architecture of leading mapping apparatuses such as CARTO '" or EnSite®, as well as
their tool sets (e.g., catheters), need not be modified as to their generic metrics (e.g.,
bipolar, quadripolar, decapolar, balloon, basket), and are not altered as the MOSFET
amplifier and its associated circuitry is adopted within the existing catheter shaft, rather,
this novel MOSFET technology can be seamlessly incorporated into the existing
hardware - and, to the operator, the change would be essentially invisible”).
Regarding Claim 12, Schachar teaches the method of claim 1 further comprising detecting an energetic event in the tissue using the HuygensTM sensor array to generate an ensemble vector map to characterize spatiotemporal organization of cardiac fibrillation (page xv: “The purpose of this collection of patents, applications, and technical observations is to develop and apply a method for detecting the energetic event by the ability of local amplifier with its inherent variable resistor (MOSFET sensor module) to generate, for example, an "ensemble vector mapping" to characterize the spatiotemporal organization of fibrillation.”).
Regarding Claim 13, Schachar teaches the method of claim 1 further comprising using the HuygensTM sensor array with a predetermined geometric configurations, including bipolar, quadripolar, decapolar, or any array with 64 or more electrodes, to enable a plurality of electrodes to simultaneously capture a complex electro-potential energetic event, with an improved SNR and sampling rate commensurable with a bandwidth and accuracy in a spatio-temporal domain (page xi: “Simply stated, a local amplifier which acts as variable resistor, and its on-site electrical ground (i.e., a ground not subject to the 5-ft. antenna/conductor, formed out of the catheter shaft, acting as a receiver/carrier for equipment located at the operating room with frequencies ranging from 50-60 Hz to 5-10 kHz, and where such an antenna is the origin for some of these noisegenerating sources). The novel approach employs pre-amplification technology which substantially improves Signal-to-Noise Ratio (SNR), Spurious-Free Dynamic Range (SFDR), signal fidelity, sampling rate, bandwidth, differentiation of far-field from nearfield components, further outlined in this introduction and the accompanying patents provided.”; page xv: “The purpose of this collection of patents, applications, and technical observations is to develop and apply a method for detecting the energetic event by the ability of local amplifier with its inherent variable resistor (MOSFET sensor module) to generate, for example, an "ensemble vector mapping" to characterize the spatiotemporal organization of fibrillation.”; page xvi: “)The operative departure of the novel technology is the incorporation of local amplification at the source using, for example, a MOSFET sensor module in an array form with geometry configurations such as bipolar, quadripolar, decapolar, or any array with 64 or more electrodes, to enable a multitude of electrodes/pads to simultaneously capture the complex electropotential energetic event, with the improved SNR and sampling rate commensurable with the bandvvidth and accuracy on the spatio-temporal domain. One of our heuristic arguments is the ability of a mature scientific theory is its predictable power, and to uniquely project an outcome based on boundary conditions that can be reproduced, where specificity of the well-formed question results in a well-defined answer.”)
Regarding Claim 14, Schachar teaches the method of claim 1 further comprising capturing bioelectric potential data, which is anchored in a measurement that reveals the physical nature of a biological substrate's electrical properties of underlying tissue to allow for interpretation of the phenomenological expression of an electrogram (EGM) and its graphical representation in the context of an energetic event, based on the dielectric (x) and conductivity (a) measurements of underlying tissue (page xix: “This technology allows for the interpretation of the phenomenological expression of the electrogram (EGM) and its graphical representation in the context of an energetic event, based on the dielectric (K) and conductivity (a) measurements of underlying tissues.”).
Regarding Claim 15, Schachar teaches the method of claim 1 further comprising connecting an electroanatomical map with an inherent physical relationship between an energy transfer function and its causal dependency on a substrate tissue as represented by an electrogram by using a HuygensTM sensor array for conducting an electrophysiological study (page xix: “Electrophysiology studies employ a variety of
devices, specifically catheters with different electrical configurations of electrodes using
magnetic as well as electrical impedance techniques to form an electroanatomical map. The fact that electroanatomical mapping fails to connect the inherent physical relationship between an energy transfer function and its causal dependency on the substrate, as represented by the electrogram, is the foundation for the utility of the local amplifier invention, exhibited herein via the use of a MOSFET sensor array for conducting electrophysiological studies.”).
Regarding Claim 16, Schachar teaches the method of claim 1 further comprising connecting phenomenological data with clinical observation so that electrical properties of a conduction path within a cardiac substrate and its etiological constituents are correlated without the need to create a causal dependency (page xvii: “the etiological as
well as morphological elements forming the substrate of a biostructure must obey
unique boundary conditions and where their specificity can be studied and
reconstructed as well as predicted. The fact that most of the EP studies are a collection
of phenomenological observations supports the contention that EP as a scientific
discipline must undergo a change which must first be organized under the tool set and
the ability of the physician community to recognize a generally accepted standard of
data capture as well as a data format. The fact that many researchers and their
publication tend to exhibit a colorful plates with interesting isochrones does not
constitute a "standard model," as the collection methods vary and its solution has a low
predictability and reproducibility value.”; page xviii: “As we survey the field of EP, we see a landscape of phenomenological collections of data with little to no specificity associated with the fact that the cellular excitable matrix is the result of specific etiological characteristics of the underlying substrate. If these data points were anchored by a robust physical and biological model, such as that which is presented here, it will enable a simple translation between the electrical map and its substrate. Hence, the substrate will be directly correlated to the pathophysiology”; page xx: “The method and exemplary apparatus which is presented enables the creation of an
electroanatomical map with high fidelity and accuracy while depicting a local electrogram with its native dynamics, its geometrical as well as its time
domain specificity, and further providing for reconstruction of the anatomical and the
extrapolated etiological characteristics of the cellular matrix by employing the MOSFET sensor array apparatus”).
Regarding Claim 17, Schachar teaches the method of claim 1 further comprising synchronously capturing spatial and temporal complexity of an energetic cardiac event using the HuygensTM sensor array to mimic underlying cardiac dynamics by localizing and precisely identifying arrhythmogenic substrates removed from fluoroscopic landmarks and lacking characteristic electrogram patterns (page xxiv: “The MOSFET sensor array and its fidelity further mimics the underlying dynamics, and will improve conventional catheter-based mapping techniques by localizing and identifying precisely the arrhythmogenic substrates that are removed from fluoroscopic landmarks and lack characteristic electrogram patterns.”).
Regarding Claim 18, Schachar teaches the method of claim 1 further comprising generating a cardiac map comprised of superimposed electric and energy (Poynting) wave maps by converging electric heart vector with the magnetic heart vector by computing an impedance (Z) value generated from the substrate (page xxvii: “Signal Anisotropy. Modeling Biopotential Activity - Poynting Energy Vector CPEV)
A second argument cited directly by analytical and clinical observations is a study by
Shachar and Farkas 23, demonstrating analytically the relationship between conduction
path and the vectorial representation of anisotropic influence of the magnetic dipole
vector on the conduction path. The preceding argument will clarify the behavior of the
Poynting energy vector (PEV) further indicating the fact that representation of the
ECG signal with its post-processing modality is a very crude approximation of the native
bioelectric signal.”).
Regarding Claim 19, Schachar teaches the method of claim 1 further comprising simultaneously localizing and mapping (SLAM) magnetic fields during a cardiac activation sequence to uncover a magnetic heart vector (MHV) by computing a Poynting energy vector (PEV) from a measured impedance vector (Z) sensed using the HuygensTM sensor array with a computational algorithm (page xxviii: “To overcome the measurement limitations and supplement the clear clinical findings of
myocardial anisotropy, we observed that production of slam magnetic fields during the
cellular activation sequence uncovers the magnetic dipole (MHV) by computing a vector
derived from Maxwell's equations, a process of data collection available only if we
derive the PEV from the impedance vector (Z) using the MOSFET sensor array
supplemented with a computational algorithm. Clinical observations reported " that
measuring the angle between vectors of an equivalent electric dipole (electric heart
vector, EHV) and magnetic dipole (MHV) provides significant corollary information about
the myocardium conductivity. The overall anisotropic case of the myocardium
conductivity is represented by a tensor. 23 The degree of anisotropic conductivity
manifestation is characterized by the angle along the transversal and axial conductivity
paths. as shown in the figure above of such a simulation”).
Regarding Claim 20, Schachar teaches the method of claim 1 further comprising measuring a phase difference, p3, between PEV and EHV to infer features of anisotropy in a myocardium (page xxviii: “The PEV derivation is based on the law of energy conservation when used for the time period between 2 QRS cycles to acquire the initial baseline data foundation to form the map. The validity of the PEV derivation is corroborated by the fact that the activation spread obeys the mathematical identity, that the PEV is directly exhibiting the E and B fields' phase angle relationship. The integral form of Maxwell's equations leads to the PEV, and to the substitution of E and Z derivations of this vector. The following set of derivations of Maxwell's second set of time varying equations provides a formal extraction of additional clinical observations by the application of a MOSFET sensor array to derive Z impedance vector, hence demonstrating that the conduction path influenced is measurable. The inverse method further supports the argument that the nature of the resultant electrogram supplemented by the use of the proposed novel apparatus (MOSFET sensor array) enables a clinical derivation of PEV from Maxwell's second set of time-varying equations. The availability of Z impedance vector by the proposed apparatus is further evidence that the complex fractionated wavefront cannot be resolved by post-processing methodology as currently practiced by the use of electrode technology”).
Regarding Claim 21, Schachar teaches the method of claim 1 further comprising differentiating far-field from near-field signal sources in a pacemaker lead by using a HuygensTM sensor array to effectively prevent false positive events (page xii, par. 1 and page xxxvi: pacemaker with local MOSFET).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-8, 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,279,876 in view of Shachar.
Regarding Claim 1, claim 1 of U.S. Patent No. 12,279,876 teaches an improvement in a method of sensing biopotentials in tissue (claim 1: tissue-based electrophysiological signals received at the plurality of electrodes) comprising: providing a Huygens sensor array characterized by native biopotential signal sensing with local amplification and signal processing at or proximate to electrode signal pickup (Claim 1: wherein the catheter tip includes an electrode region forming a most distal portion of the catheter tip, a circuitry region forming a least distal portion of the catheter tip… one or more multiplexers disposed in the circuitry region and in communication with the plurality of electrodes, the one or more multiplexers being configured to combine tissue-based electrophysiological signals received at the plurality of electrodes; amplification circuitry disposed in the circuitry region and in communication with the one or more multiplexers, the amplification circuitry being configured to amplify the combined tissue-based electrophysiological signals; digitizing circuitry disposed in a circuitry region and in communication with the amplification circuitry, the digitizing circuitry being configured to digitize the amplified and combined tissue-based electrophysiological signals); and sensing the native electrical biopotential signal using at least one electrode on the Huygens catheter to generate a well-formed waveform of the biopotential showing electrical properties indicative of the tissue.
Claim 1 of U.S. Patent No. 12,279,876 does not explicitly disclose the waveform having a SFDR of at least 24.9dB and SNR of at least -13dB. However, Shachar teaches an analogous method of detecting EP signals with a catheter having local MOSFETs and achieving an SFDR of 24.9dB and an SNR of -13dB (e.g. abstract: MOSFET sensor array signal is well-formed with clear cardiac properties, an SFDR of 24.9dB and an SNR of -13dB). Therefore, it would have been obvious to a person having ordinary skill in the art to generate a waveform having a SFDR of at least 24.9dB and a SNR of at least -13dB, in a method according to the teaching of Claim 1, as taught by Shachar, as this would only amount to applying a known technique to a known device and method ready for improvement to yield the predictable result of sensing native biopotentials with high fidelity.
Regarding Claim 2, claim 1 of U.S. Patent No. 12,279,876 as modified in Claim 1, teaches the method of claim 1 where the tissue comprises cardiac tissue and where the biopotential signal comprises a native cardiac waveform (claim 1: EP catheter).
Regarding Claims 3-7, claim 2 of U.S. Patent No. 12,279,876 as modified in Claim 1 (claim 2 depends of claim 1, thus is also modified), teaches where the biopotential signal comprises a manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue, where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises an energetic event characterized by vectorial direction and magnitude, where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises a representation of underlying substrate composition of the tissue, where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises a biopotential measurement using the Huygens sensor array to generate a representation of the energy contents on the spatial and time domains of a complex cardiac waveform, leading to a recursive relationship between a graphical representation of the cardiac waveform and an underlying biopotential substrate which is a source of the cardiac waveform, where the manifestation of underlying electrochemical activity of a biological substrate corresponding to the tissue comprises a mapping technique which characterizes global dynamics of cardiac wavefront activation based on cellular etiology and corresponding dielectric and conductivity characteristics of the tissue representing complex inter-relationships of avalanche dynamics translated through a measured myocardial space arising from spatial and temporal ionic potentials measured by a local amplifier Huygens sensor array [all limitations of Claims 3-7 are drawn to the sensed biopotential signal itself and what it may “manifest” to a hypothetical observer, as in, the underlying biological qualities of the signal and the capabilities that the signal may unlock, rather than adding any steps to the method. Such underlying qualities and capabilities are necessarily met by claim 2 of U.S. Patent No. 12,279,876 as modified above, as claim 2 meets all the positively recited method steps (evidence to this, is the disclosure of Shachar, as has been discussed above in the respective claims in the 103 rejection section)].
Regarding Claim 8, claim 3 of U.S. Patent No. 12,279,876 as modified in Claim 1 (claim 3 depend on Claim 1 thus is also modified), teaches the method of claim 1 where sensing a native electrical biopotential signal using at least one electrode on a catheter with an amplifier circuit placed on the inner surface of the at least one electrode in the Huygens sensor array comprises sensing by performing impedance spectroscopy (Claim 3: herein the amplification circuitry comprises a local amplifier active sensor array that performs impedance spectroscopy on the combined tissue-based electrophysiological signals.).
Regarding Claims 14-15, claim 2 of U.S. Patent No. 12,279,876 as modified in Claim 1 (claim 2 depend on Claim 1 thus is also modified), teaches the method of claim 1, further comprising capturing bioelectric potential data, which is anchored in a measurement that reveals the physical nature of a biological substrate's electrical properties of underlying tissue to allow for interpretation of the phenomenological expression of an electrogram (EGM) and its graphical representation in the context of an energetic event, based on the dielectric (x) and conductivity (a) measurements of underlying tissue, further comprising connecting an electroanatomical map with an inherent physical relationship between an energy transfer function and its causal dependency on a substrate tissue as represented by an electrogram by using a Huygens sensor array for conducting an electrophysiological study [all limitations of Claims 14-15 are drawn to the sensed biopotential signal itself, as in, the inherent underlying biological qualities of the signal and the capabilities that the signal may unlock, rather than adding any steps to the method. Such underlying qualities and capabilities are necessarily met by claim 2 of U.S. Patent No. 12,279,876 as modified above, as claim 2 meets all the positively recited method steps (evidence to this, is the disclosure of Shachar, as has been discussed above in the respective claims in the 103 rejection section)].
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/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
MANOLIS PAHAKIS /M.P./
Examiner
Art Unit 3792